Trial Outcomes & Findings for Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches (NCT NCT03767062)
NCT ID: NCT03767062
Last Updated: 2020-01-22
Results Overview
Range Pain 0-10, 0: No pain, 10: Worst Pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Post treatment (4 weeks later)
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
Topiramate
Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
Topamax: An antiepileptic agent used for migraine prophylaxis.
|
Greater Occipital +Supratrochlear Nerve Block
Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches
Baseline characteristics by cohort
| Measure |
Topiramate
n=45 Participants
Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
Topamax: An antiepileptic agent used for migraine prophylaxis.
|
Greater Occipital +Supratrochlear Nerve Block
n=45 Participants
Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post treatment (4 weeks later)Range Pain 0-10, 0: No pain, 10: Worst Pain
Outcome measures
| Measure |
Topiramate
n=37 Participants
Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
Topamax: An antiepileptic agent used for migraine prophylaxis.
|
Greater Occipital +Supratrochlear Nerve Block
n=41 Participants
Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
|
|---|---|---|
|
Visual Analog Scale
Pretreatment (Baseline)
|
8.3 units on a scale
Standard Deviation 0.8
|
8.4 units on a scale
Standard Deviation 0.7
|
|
Visual Analog Scale
Post treatment (4 weeks later)
|
5.3 units on a scale
Standard Deviation 1.2
|
5.3 units on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Post treatment (4 weeks later)Number of headaches patients suffer in a month.
Outcome measures
| Measure |
Topiramate
n=37 Participants
Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
Topamax: An antiepileptic agent used for migraine prophylaxis.
|
Greater Occipital +Supratrochlear Nerve Block
n=41 Participants
Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
|
|---|---|---|
|
Attack Frequencies
Pretreatment (Baseline)
|
21.2 headaches per month
Standard Deviation 3.1
|
20.9 headaches per month
Standard Deviation 2.7
|
|
Attack Frequencies
Post treatment (4 weeks later)
|
4.7 headaches per month
Standard Deviation 2.8
|
5.9 headaches per month
Standard Deviation 2.9
|
Adverse Events
Topiramate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Greater Occipital +Supratrochlear Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topiramate
n=45 participants at risk
Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
Topamax: An antiepileptic agent used for migraine prophylaxis.
|
Greater Occipital +Supratrochlear Nerve Block
n=45 participants at risk
Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
Greater Occipital Nerve Block + Supratrochlear Nerve Block: An injection to paralyze the occipital and supratrochlear nerves.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
4.4%
2/45 • Number of events 2 • 4 weeks
|
0.00%
0/45 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place